Informed Consent is a process. Our clinical research staff/BMT physician will meet with you to review the clinical trial in detail. We encourage you to bring family or friends to meet our research staff with you. The research nurse or associate will provide you with enough information about the requirements of participating in a trial for you to make a conscious, voluntary decision. Once you have been provided enough information and have had all your questions answered, you will be asked to sign consent. Please review the NSH IRB generic Informed Consent. This template is for all clinical trial consents. Each clinical trial consent will provide specific details about what is required of you to participate in the study.

The consent will explain:

• The clinical trial, the procedures you will undergo during the trial, the risks, benefits and alternatives to participating in the clinical trial as well as how and to what extent your records are kept confidential, who can answer questions about your rights as a research subject and what happens in the event of an injury as a result of the study.

• If you are a woman of child bearing potential or the partner of a woman of child bearing potential, pregnancy risks and risks to unborn children will be discussed. You will also discuss the need for effective birth control during and after your participation in the trial.

• After you have signed the consent, it is the responsibility of your physician, mid-level practitioner and research nurse to make sure your participation in the trial remains voluntary.

• You will be notified of any new information regarding the clinical trial that may affect your willingness to continue.

• You may withdraw your consent to participate in the research study at any time without penalty.

If you have questions about how research is conducted at Northside Hospital or about participating in a clinical research study, the clinical research department (404-851-8238) will be able to provide information to you.